For drug developers working on an injectable medication, getting a new molecule to the clinic quickly and efficiently is a top priority—but getting there with a secure supply of product is equally important.
Filling a batch of clinical trial material is a critical step in that process. Focusing on a few key areas of this vital fill and finish project can help you set it up for success.
Early on, drug developers spend significant time nurturing their molecule in a laboratory environment, producing small volumes. In this phase of development, the focus is on understanding the molecule – it’s characteristics, safety, and therapeutic potential. But when it comes time for in-human trials, two new challenges kick in: not only producing significantly greater volumes to support a trial, but also developing a high quality, scalable filling process that meets all safety and quality requirements for in-human use.
With clinical and financial milestones on the line, parenteral drug developers need to take a smart, strategic approach to filling their clinical trial material – one that not only streamlines their transition to the clinic but also could set the stage for additional downstream successes. As clinical manufacturing expert Garath Duffy explains in our new video series on early-stage fill and finish, a smart, strategic approach often comes down to these key areas of focus:
1. Building a proactive plan
Successfully completing a first clinical batch project takes time, and more material than what’s needed just for clinical trials. Always start by building a schedule that allows for all the additional steps that need to be taken, and plan for a batch size that accommodates extra testing and analysis.
2. Preparing the product
As you get ready to move your product to a manufacturing facility for the first time, both regulators and your CDMO partner will need to know significantly more about the molecule to ensure it’s ready for release to clinical trials – and their test participants. Before your IND is filed – and before the batch is filled – important additional tests are required to assess the product’s safety, stability, and behavior outside the lab.
3. Sourcing the right expertise
A clinical fill and finish project is a multidisciplinary effort that often requires nascent drug developers to onboard a range of new roles.
Start thinking about how and where you’ll find the multidisciplinary skills you need to successfully develop and execute your project – including regulatory/CMC, analytics, process development, project management, aseptic filling, quality assurance/control, and more. You may want to enlist consultants and/or a CDMO partner like Vetter that can fulfill all the necessary roles.
4. Implementing best practices
Filling clinical trial materials is often the first time a new molecule needs to be produced in a way that complies with current good manufacturing practices (cGMPs), the continually evolving standards which help ensure drug products are safe for human use.
To align with these best practices, your manufacturing process will need a quality system that integrates three critical workflows: Qualification of the equipment and personnel who will handle the product; validation of the processes used to fill it; and documentation of every step to regulatory standards. The right CDMO can be an invaluable partner to help you build that system.
Focus on these four important topics, and your team can get your clinical batch project off to a successful start and pave the way to important future milestones!